2026 data FDA MAUDE openFDA FDA Class II

Hearing Aid, Air-Conduction With Wireless Technology, Prescription

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

OpenFDA device adverse-event casebook.

FDA Class II (moderate risk, special controls required), regulated under 21 CFR §874.3305 (Ear, Nose, Throat panel).

FDA MAUDE casebook

openFDA event book Hearing Aid LIGHT-BOOK · MAUDE

#788 of 1000 · 673 reports · 2013–2026

  • BOOK 673 reports
  • RANK #788 of 1000
  • DEATH 0 death-typed
  • INJ 224 injury-typed
  • MALF 448 malfunction
  • SPAN 2013–2026
  • PEAK 2024: 188
  • PHOTO Forceps

Nearest event-volume peer: Forceps, General & Plastic Surgery (0 report gap)

Hearing Aid, Air-Conduction With Wireless Technology, Prescription sits #788 of 1000 among tracked device types with 673 MAUDE reports spanning 2013–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Similar-volume device →

Injury-coded reports run above the device-type norm

Hearing Aid carries 33.3% INJURY-coded reports, 3.0pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 33.3% corpus 30.3% · above corpus mean (+3.0 pp)
  • MALF 66.6% corpus 64.8% · above corpus mean (+1.7 pp)

Lead product-problem code Overheating of Device is 26% of coded problems · Top event location is 85% of location-tagged rows .

Hearing Aid in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Hearing Aid, Air-Conduction With Wireless Technology, Prescription carries 673 MAUDE reports, ranked #788 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Malfunction 448 (66.6%)
Injury 224 (33.3%)
Other 1 (0.1%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

367 (52.5%)
Other 145 (20.7%)
Required Intervention 116 (16.6%)
Disability 38 (5.4%)
O 8 (1.1%)
R 7 (1.0%)
S 6 (0.9%)
Hospitalization 6 (0.9%)
H 4 (0.6%)
C 1 (0.1%)
Life Threatening 1 (0.1%)

Top Product Problems

Overheating of Device 171
Detachment of Device or Device Component 145
Patient Device Interaction Problem 83
Product Quality Problem 49
Patient-Device Incompatibility 33
Break 30
Adverse Event Without Identified Device or Use Problem 26
Fracture 18
Insufficient Device Problem Information 18
Material Deformation 12
Material Integrity Problem 11
Appropriate Device Problem Term/Code Not Available 10
Temperature Problem 10
No Apparent Adverse Event 9
Biocompatibility 8
Battery Problem 7
Inadequacy of Device Shape and/or Size 7
Output Problem 7
Lack of Effect 6
Use of Device Problem 6

Yearly Trend

13
2013: 1
15
2015: 3
16
2016: 2
17
2017: 1
18
2018: 2
19
2019: 14
20
2020: 59
21
2021: 16
22
2022: 101
23
2023: 158
24
2024: 188
25
2025: 73
26
2026: 55

Reports fell to 73 in 2025, down from an average of 173 in the two years before.

Related Entities for Hearing Aid, Air-Conduction With Wireless Technology, Prescription

Event Locations

573 (85.1%)
I 85 (12.6%)
NO INFORMATION 6 (0.9%)
HOME 5 (0.7%)
OTHER 4 (0.6%)

Nationwide devices with a comparable report-volume footprint

Hearing Aid carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (673 here).

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Disclaimer: MAUDE figures for Hearing Aid are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.

Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Hearing Aid; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.